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Evaluate the Efficacy and Safety of LO2A Eye Drops for Symptomatic Improvement of Dry Eye in Patients With Sjögren's Syndrome

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ClinicalTrials.gov Identifier: NCT03319420
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Ocuwize LTD

Brief Summary:

Dry eye complaints occur in 5.5 to 33.7% of the population, and are ranked as the most frequent symptoms of patients visiting ophthalmologists. Dry eye syndrome is caused by the reduced production and/or improper quality of the tear film. One of the causes of reduced tear production is Sjögren's syndrome. Sjögren's is estimated to affect up to 4 million patients in the US alone. It affects mostly middle aged women (40-50 years of age) with a female to male prevalence ratio of 9:1.

The current study seeks to evaluate the safety and efficacy of LO2A ophthalmic solution in the symptomatic treatment of dry eye in patients with Sjögren's syndrome. This study will be conducted in compliance with the protocol, GCP,and applicable regulatory requirements.


Condition or disease Intervention/treatment Phase
Dry Eye Due to Sjögren's Syndrome Drug: LO2A eye drops Drug: Systane Ultra UD Phase 4

Detailed Description:

This is a randomized, double-masked, comparative study versus Systane ultra UD, to evaluate the efficacy and safety of LO2A eye drops for symptomatic improvement of dry eye in Patients with Sjögren's syndrome. Eligible patients will be randomly assigned in a 1:1 ratio to one of two treatment groups, LO2A or Systane ultra UD, respectively.

The study will consist of a screening period of up to two weeks and a 3-month double blind treatment period (topical application of eye drops four times daily)

Up to 60 subjects are planned to be recruited to this study, randomized to one of two treatment arms using a 1:1 active (LO2A) to Systane ultra UD ratio.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized, double-Masked, comparative study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Investigator staff involved in the dispensation of study treatments and treatment compliance checks will not be involved in data collection - doublemasked treatment design.
Primary Purpose: Treatment
Official Title: A Randomized, Double-Masked, Comparative Study Versus Systane Ultra UD, to Evaluate the Efficacy and Safety of LO2A Eye Drops for Symptomatic Improvement of Dry Eye in Patients With Sjögren's Syndrome
Actual Study Start Date : March 29, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Systane

Arm Intervention/treatment
Experimental: LO2A
1 drop of sodium hyaluronate instilled into each eye 4 times daily
Drug: LO2A eye drops
Sodium hyaluronate

Active Comparator: Systane Ultra UD
1 drop of Systane Ultra UD instilled into each eye 4 times daily
Drug: Systane Ultra UD
Active Ingredients; Polyethylene Glycol Propylene Glycol




Primary Outcome Measures :
  1. Change in corneal / conjunctival staining score using the National Eye Institute/Industry(NEI) Industry Grading System [ Time Frame: 3 months form the basline ]
    NEI/Industry Workshop Conjunctival Staining Grading System. Devitalized epithelial cells of the bulbar conjunctiva are stained with lissamine green and can graded across six zones The scores for each zone (0-3) are summed to obtain an overall score for each eye (0-18.( The higher the results, the more severe the dryness of the eye.


Secondary Outcome Measures :
  1. Change in Ocular Surface Disease Index (OSDI) questionnaire score. [ Time Frame: 1 and 3 months from the basline visit ]
    The OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease.

  2. Change in corneal / conjunctival staining score using the National Eye Institute/Industry(NEI) Industry Grading System [ Time Frame: After one month ]
    NEI/Industry Workshop Conjunctival Staining Grading System. Devitalized epithelial cells of the bulbar conjunctiva are stained with lissamine green and can graded across six zones The scores for each zone (0-3) are summed to obtain an overall score for each eye (0-18.( The higher the results, the more severe the dryness of the eye.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female of any race and ≥ 18 years of age.
  • Willing and able to provide voluntary written informed consent.
  • Primary or secondary Sjögren's syndrome according to the American- European Consensus Classification Criteria (2002).
  • Females of childbearing potential must agree to use effective contraception consistently throughout the study (such as hormonal contraception or two forms of barrier contraception) and have a negative urine pregnancy test at screening.
  • Willing and able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

  • Subject has concurrent, uncontrolled medical condition, or psychiatric illness which could place him/her at unacceptable risk.
  • Subjects with pterygium.
  • Subjects with active, allergic keratoconjunctivitis, or conjunctivitis of infectious origin.
  • Subjects with blepharitis requiring treatment.
  • Subjects with a history of surgery affecting the eye surface, as well as eye injuries within 3 months of screening.
  • Subjects currently using any topical ophthalmic treatment (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial.
  • Female subjects who are pregnant or breast-feeding, or plan to become pregnant during the study.
  • Subjects that have started or changed the dose of chronic systemic medication within 7 days of Visit 1.
  • Known hypersensitivity to sodium hyaluronate or any LO2A excipients (glycerol and Carbomer 981) or any of the components in Systane Ultra UD.
  • Active abuse of alcohol or drugs.
  • Any condition, which in the opinion of the Investigator, would place the patient at an unacceptable risk if participating in the study protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03319420


Contacts
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Contact: Sergiu Socea, MD 972 (4) 777-2489 sergiusoc@gmail.com
Contact: Meital Abecasis 972 (4) 777-2489 m_abecassis@rambam.health.gov.il

Locations
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Israel
Rambam Recruiting
Haifa, Israel
Contact: Sergeu Socae, M.D       sergiusoc@gmail.com   
Contact: Meital       m_abecassis@rambam.health.gov.il   
Ichilov medical center Tel Aviv Not yet recruiting
Tel Aviv, Israel
Contact: Zohar Villner, MD    972-36974165    zoharhw@tasmc.health.gov.il   
Sponsors and Collaborators
Ocuwize LTD

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Responsible Party: Ocuwize LTD
ClinicalTrials.gov Identifier: NCT03319420     History of Changes
Other Study ID Numbers: WP-LO2A-03
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Dry Eye Syndromes
Xerostomia
Mouth Diseases
Syndrome
Keratoconjunctivitis Sicca
Sjogren's Syndrome
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Stomatognathic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Ophthalmic Solutions
Hyaluronic Acid
Pharmaceutical Solutions
Adjuvants, Immunologic
Immunologic Factors